2023
Standardized Definitions for Efficacy End Points in Neoadjuvant Breast Cancer Clinical Trials: NeoSTEEP
Litton J, Regan M, Pusztai L, Rugo H, Tolaney S, Garrett-Mayer E, Amiri-Kordestani L, Basho R, Best A, Boileau J, Denkert C, Foster J, Harbeck N, Jacene H, King T, Mason G, O'Sullivan C, Prowell T, Richardson A, Sepulveda K, Smith M, Tjoe J, Turashvili G, Woodward W, Butler L, Schwartz E, Korde L. Standardized Definitions for Efficacy End Points in Neoadjuvant Breast Cancer Clinical Trials: NeoSTEEP. Journal Of Clinical Oncology 2023, 41: 4433-4442. PMID: 37433103, PMCID: PMC10522109, DOI: 10.1200/jco.23.00435.Peer-Reviewed Original ResearchConceptsSecondary end pointsPathologic complete responseClinical trialsEnd pointStandardized definitionsHormone receptor-positive diseaseCurative-intent surgeryNeoadjuvant clinical trialsPathologic nodal evaluationResidual invasive cancerEfficacy end pointReceptor-positive diseaseBreast cancer clinical trialsResidual cancer burdenAlternative end pointsTrial end pointsRegional lymph nodesCancer end pointsCross-trial comparisonsSurvival end pointsEnd point definitionsCancer clinical trialsDrug Administration (FDA) regulatory considerationsEfficacy outcomesComplete response
2016
Testing Violations of the Exponential Assumption in Cancer Clinical Trials with Survival Endpoints
Han G, Schell MJ, Zhang H, Zelterman D, Pusztai L, Adelson K, Hatzis C. Testing Violations of the Exponential Assumption in Cancer Clinical Trials with Survival Endpoints. Biometrics 2016, 73: 687-695. PMID: 27669414, PMCID: PMC6093291, DOI: 10.1111/biom.12590.Peer-Reviewed Original Research
2013
Concordance Between CYP2D6 Genotypes Obtained From Tumor-Derived and Germline DNA
Rae JM, Regan MM, Thibert JN, Gersch C, Thomas D, Leyland-Jones B, Viale G, Pusztai L, Hayes DF, Skaar T, Van Poznak C. Concordance Between CYP2D6 Genotypes Obtained From Tumor-Derived and Germline DNA. Journal Of The National Cancer Institute 2013, 105: 1332-1334. PMID: 23958736, PMCID: PMC3888280, DOI: 10.1093/jnci/djt204.Peer-Reviewed Original ResearchConceptsCYP2D6 genotypeCYP2D6 metabolic phenotypeBreast cancer patientsMetabolic phenotypeAnti-estrogen tamoxifenCancer clinical trialsCancer patientsClinical trialsTumor alterationsGermline DNAConflicting resultsPatientsTumorsTissue sourcesGenotype association studiesConcordanceGenotypesPhenotypeAssociation studiesFFPETTamoxifenEndoxifenWBCCYP2D6Trials
2011
Proposals for uniform collection of biospecimens from neoadjuvant breast cancer clinical trials: timing and specimen types
Loi S, Symmans WF, Bartlett J, Fumagalli D, Veer L, Forbes JF, Bedard P, Denkert C, Zujewski J, Viale G, Pusztai L, Esserman LJ, Leyland-Jones BR. Proposals for uniform collection of biospecimens from neoadjuvant breast cancer clinical trials: timing and specimen types. The Lancet Oncology 2011, 12: 1162-1168. PMID: 21684810, DOI: 10.1016/s1470-2045(11)70117-6.Peer-Reviewed Original ResearchConceptsNorth American Breast Cancer GroupBreast International GroupClinical trialsBiopsy procedureNeoadjuvant breast cancer trialsNeoadjuvant clinical trialsBreast cancer clinical trialsBreast cancer groupBreast cancer trialsStart of treatmentCancer clinical trialsNational Cancer InstituteNeoadjuvant trialsDefinitive surgeryNeoadjuvant treatmentCancer groupStudy protocolCancer trialsBreast cancerCancer InstituteUniform collectionTumor tissueBlood collectionTrialsSpecimen types